AB0409 FRENCH REAL LIFE EFFECTIVENESS DATA FOR TOFACITINIB AT 1 YEAR IN PATIENTS WITH RHEUMATOID ARTHRITIS: INTERIM RESULTS OF THE OBSERVATIONAL STUDY, DeFacTo
Authors: C. Gaujoux-Viala, A. Basch, S. Lassoued, F. Coury-Lucas, M. Kessouri, N. Mammar, Y. Brault, T. Lequerre, C. Salliot
Journal: Annals of the Rheumatic Diseases (2022)

Background Tofacitinib, an oral Janus Kinase inhibitor, is indicated in the treatment of adult patients (pts) with active, moderate to severe rheumatoid arthritis (RA). At the present time we have no data concerning its efficacy in a French RA population in a real-life setting. Objectives DeFacTo, is an on-going observational study the principal goal of which is to identify factors predictive of Tofacitinib drug survival in RA patients in real life. Methods These are the results of interim descriptive analyses of effectiveness data after 1 year of follow up. Results Of the 313 pts enrolled in the study, 276 pts were included in the effectiveness analysis (POP1), 219 of whom were patients with a ≥1-year follow-up (POP2) including 122 patients who, as of 15 March 2021, were continuing to take Tofacitinib therapy. At inclusion, POP1 (n=276) was composed of 77.9% females of mean (± SD) age 59.7 ± 11.7 years, having a median disease duration of 9.1 years [Q1;Q3: 4.1; 19.2], TJC 7.5 ± 5.9 and SJC 5.3 ± 5.1; 115 patients presented with erosions, 206 had RF+ and 202 had ACPA+. The median CRP value was 7.4 [: 3.0; 20.0] mg/l, DAS28-4-CRP was 4.6 ±1.1, and the FACIT-Fatigue score was 28.3 ± 11.3. In all, 96.7% of the pts had received prior treatment with ≥1 csDMARDs, 65.2% with b/tsDMARDs (median = 2 [1; 4]). Tofacitinib was prescribed in combination with a csDMARD in 58.3% of cases. The baseline characteristics of the 122 patients still taking tofacitinib at 12 months were comparable to those of POP1. Results showed continued treatment with tofacitinib in 85.3% of pts with mean duration of treatment of 368 ± 197.1 days and reductions from baseline in the parameters of inflammatory markers, pain and the DAS28 activity scores; 20% of 122 pts were in DAS28-CRP remission (Table 1). Safety findings were similar to those reported previously in clinical studies 1 2 . Table 1. Baseline characteristics and effectiveness at 12 months Patient characteristics Variables: mean ± SD or % pts Inclusion, n=219 At 12 months, n=122 * PtGA (VAS, mm) 60.6 ± 20.8 29.8 ± 22.8 Pain (VAS, mm) 57.3 ± 24.8 30.1 ± 25.7 CRP (mg/l) 15.5 ± 21.9 7.9 ± 13.3 DAS28-4-CRP 4.6 ± 1.0 2.8 ± 1.1 DAS28-4-ESR 4.9 ± 1.1 3.3 ± 1.2 Effectiveness Inclusion. n=219 At 12 months. n=219 ⱡ LDA, % pts - DAS28-CRP ≤3.2 6.8 28.8 - DAS28-ESR ≤3.2 4.6 21.5 Remission, % pts - DAS28-CRP &lt;2.6 3.7 20.1 - DAS28-ESR &lt;2.6 2.7 9.6 Conclusion These real-life interim results for Tofacitinib in RA patients provide information on its use in France: with prescriptions for single drug therapy in 41.7% of cases, the effectiveness of Tofacitinib is confirmed as comparable to that found in clinical studies 1-3 . References [1]Burmester G et al . Lancet. 2013;381:451-460 [2]Fleischman R et al . Lancet 2017;390:457-68 [3]Wollenhaupt et al . Arthritis Research &amp; Therapy (2019) 21:89 https://doi.org/10.1186/s13075-019-1866-2 Acknowledgements To all investigators involved in this study, and all patients included in this study Disclosure of Interests Cécile Gaujoux-Viala Speakers bureau: AbbVie; Amgen; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Amgen; Boeringhe; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB, Andre BASCH Speakers bureau: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB, Consultant of: Janssen, Novartis, Amgen, BMS, Abbvie, Lilly, Pfizer, MSD, UCB,, Slim Lassoued: None declared, Fabienne COURY-LUCAS Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, MSD, Novartis and Pfizer, Grant/research support from: AbbVie, Biogen, Roche Chugai, Pfizer, and UCB,, Meriem Kessouri Shareholder of: Pfizer, Employee of: Pfizer, Nadir Mammar Shareholder of: Pfizer, Employee of: Pfizer, Yves Brault Employee of: Pfizer, Thierry Lequerre Consultant of: Abbvie, BMS, Boeringher, Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche – Chugai, Sanofi, UCB,, Carine Salliot Consultant of: Biogen, Lilly, Novartis, Roche Chugai, Pfizer